PROCEDURE AND RECORD MAINTAIN OF LOAN AND LICENCE BASIS JOB WORK

[nandankumar roy]

DEAR SIR,

WE ARE NOW GOING TO LOAN AND LICENCE BASIS JOB WORK FOR MANUFACTURING OF PHARMA PRODUCTS.PLEASE HELP WHAT WE HAVE  TO FOLLOW PROCEDURES AND RECORD MAINTAINANCE FOR THAT JOB WORK.

NANDANROY

[Mahir S]

1) Under Drugs and Cosmetics Act, the scheme of loan licensee is permissible and the concept of manufacturer as stipulated under the Central Excise Act also covers such licensees being treated as manufacturers.

2) Application for loan licence to be made under Rule 138-A of the Drugs and Cosmetics Rules, 1945.

3) Prior Intimation to be given to the excise department.

4) regarding excise, raw material received from loan licensee to be strored separately and clearances to be effected on payment of excise duty and to be shown separately in ER 1 returns.

5) Separate register for receipt and disposal of raw materials and goods manufactured to be maintained.

6) The production should be strictly in accordance with the input outout norms.

7) Prior agreement with the loan licesee is must.

AI Summary

Pharmaceutical Manufacturing on Loan License: Rule 138-A Compliance and Record-Keeping Requirements Explained A query was raised regarding the procedures and record maintenance for conducting job work on a loan and license basis for manufacturing pharmaceutical products. The response outlined that under the Drugs and Cosmetics Act, loan licensees are considered manufacturers. An application must be submitted under Rule 138-A of the Drugs and Cosmetics Rules, 1945, with prior notification to the excise department. Raw materials from loan licensees should be stored separately, with clearances made upon excise duty payment and reported in ER 1 returns. A separate register for materials and manufactured goods is necessary, production must follow input-output norms, and a prior agreement with the loan licensee is required.